NCT00854828

A Multicenter Prospective Study of Quality of Life in Adult Scoliosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 286 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter study evaluating the effectiveness of nonoperative and operative treatments. The investigators wish to identify important clinical and radiographic determinants of outcomes in the management of adults with symptomatic lumbar scoliosis (ASLS). Note: Enrollment was complete July 2014. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) funding ended 2/28/17. We continue to follow enrolled subjects while we seek additional funding to follow all subjects through 8 years.

Detailed description

Specific Aim #1: Compare the outcomes of surgery and nonoperative treatment in patients aged 40 to 80 with ASLS defined as a lumbar curve with a coronal Cobb measurement ≥ 30°, and either of the following: Oswestry (ODI) score of 20 or more; or Scoliosis Research Society Quality of Life instrument (SRS-QOL) score of 4.0 or less, in the domains of pain, function and/or appearance. Specific Aim #2: Evaluate the impact of patient factors (age, gender, socioeconomic status, education) and comorbidities \[mental health, body mass index (BMI) and bone mineral density (BMD)\] on adverse events and treatment outcomes for both the nonoperative and operative arms. Incorporate these variables into a prediction model to help identify those patients most likely to benefit from either a surgical or nonoperative approach

Conditions

• Scoliosis

Interventions

Type	Name	Description
PROCEDURE	Surgical intervention	Surgical intervention as appropriate for adults with symptomatic lumbar scoliosis
OTHER	Non-operative intervention	Non operative intervention as appropriate for treatment of adults with symptomatic lumbar scoliosis such as: injections, medications, physical therapy, etc.

Timeline

• Start date: 2010-04-01
• Primary completion: 2017-02-28
• Completion: 2017-02-28
• First posted: 2009-03-03
• Last updated: 2021-09-14
• Results posted: 2021-09-14

Locations

9 sites across 2 countries: United States, Canada